Proton-Pump Inhibitors May Be Overprescribed in Infants

Laurie Barclay, MD

October 21, 2011

October 21, 2011 — Gastroesophageal reflux disease (GERD) may be overdiagnosed in the pediatric population, resulting in overprescription of proton-pump inhibitors (PPIs) to infants, according to an expert commentary published online October 20 in the Journal of Pediatrics.

Acid-suppressing drugs, including PPIs, are approved by the US Food and Drug Administration (FDA) only for children older than 1 year. However, prescription of PPIs to infants under 12 months of age has become increasingly widespread during the past 10 years.

Parents often seek medical attention for their infant's symptoms of frequent spitting up, irritability, and unexplained crying, but these symptoms are common and are seldom explained by GERD in infants who are otherwise healthy. Most 'reflux' in this age group is not acidic because frequent feedings have buffered the stomach contents.

"[I]n the absence of better information and physician guidance and fed by advertising and misinformation on the Internet, distressed parents take their concerns to doctors, who very frequently comply and prescribe acid-suppressing medications for symptoms and signs that, in most cases, are not GERD," Eric Hassall, MBChB, FRCPC, FACG, staff gastroenterologist at Sutter Pacific Medical Foundation in San Francisco, California, and an advisor to the FDA, said in a news release. "We are medicalizing normality. In most infants, these symptoms are 'life,' not a disease, and do not warrant treatment with drugs, which can have significant adverse effects."

About 80% of children needing long-term treatment for chronic GERD have predisposing conditions, which may include neurologic disease, repaired congenital esophageal anomalies, chronic lung disease, hiatal hernia, strongly positive family history for GERD or associated conditions, or obesity. GERD is typically neither chronic nor severe in children without these risk factors.

Evidence to date suggests that PPIs are no more effective than placebo in relieving symptoms of spitting up, irritability, or unexplained crying in most infants. Furthermore, these symptoms are typically normal in this age group and generally resolve spontaneously over time as the infant matures.

Prescription of PPIs to infants is not without adverse effects because gastric acid protects against infection and ensures proper digestion. Use of PPIs in infants without GERD may increase the risk for pneumonia, gastroenteritis, and other infections, as well as for malabsorption of nutrients, including magnesium, calcium, and vitamin B12.

Clinical Implications

Practical strategies recommended by Dr. Hassall include the following:

  • Diagnostic testing for GERD has a very limited role in infants. Intraesophageal pH study is seldom helpful.

  • Endoscopy is likely to be helpful only when symptoms are very severe, with anemia, failure to thrive, or chronic forceful vomiting or chronic cough.

  • Barium study or ultrasound examination is indicated only for infants with persistent projectile vomiting, to identify an anatomic obstruction.

  • Begin with nonpharmacologic interventions, such as changing the maternal diet for breast-fed infants or providing hypoallergenic formulas for bottle-fed infants.

  • Provide explanation and reassurance, with instruction in nonanalgesic, non-nutritive soothing maneuvers, such as rhythmic rocking and patting 2 to 3 times per second in a quiet environment.

  • If symptoms are severe, and there is strong suspicion of GERD, or if nonpharmacologic interventions are ineffective, consider a trial with an acid-suppressing medication for a time-limited period of 2 weeks.

"In most cases, it is not the spitting up that should be treated," Dr. Hassall concludes. "The real issue is the unexplained crying, which causes real and considerable distress and concern for parents. It is important for pediatricians to acknowledge their concerns, explain the spectrum of normal infant behavior, discuss the range of measures available, start implementation, and be available for follow-up."

Dr. Hassall has disclosed no relevant financial relationships.

J Pediatrics. Published online October 20, 2011. Full text

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